a single-arm, multicenter, prospective clinical study of mitoxantrone liposome combined with chidamide and azacitidine in the treatment of relapsed and refractory peripheral t-cell lymphoma

Conditions: Peripheral T Cell Lymphoma

Summary: to evaluate the efficacy and safety of mitoxantrone hydrochloride liposome injection combined with chidamide and azacitidine in the treatment of relapsed and refractory peripheral t-cell lymphoma


Eligibility criteria:
inclusion criteria: 1. patients fully understand this study, voluntarily participate in and sign an informed consent form (icf); 2. age: 18\~75 years old; 3. expected survival time ≥ 3 months; 4. histopathologically confirmed ptcl, one of the following subtypes: (1) peripheral t-cell lymphoma unspecified (ptcl-nos) (2) angioimmunoblastic t-cell lymphoma (aitl) (3) anaplastic large t-cell lymphoma (alcl), alk+ (4) anaplastic large t-cell lymphoma (alcl), alk- (5) other subtypes of ptcl that the researchers believe can be enrolled; 5. relapsed/refractory patients who have received at least first-line systemic therapy with anthracycline-containing regimens in the past. relapse was defined as relapse after cr or progression after pr; refractory was defined as previous systemic chemotherapy treatment, 2 cycles of response evaluation as pd, or 4 cycles of response evaluation as sd; 6. there must be at least one evaluable or measurable lesion that meets the lugano2014 criteria: lymph node lesions, measurable lymph nodes should be \>1.5cm in length; non-lymph node lesions, measurable extranodal lesions should be \>1.0cm in length; 7. ecog score 0-2 points; 8. bone marrow function: neutrophil count ≥1.5×109/l, platelet count ≥75×109/l, hemoglobin ≥80g/l (the neutrophil count in patients with bone marrow involvement can be relaxed to ≥1.0×109/l, platelet count can be relaxed to ≥50×109/l, and hemoglobin can be relaxed to ≥75 g/l); liver and kidney function: serum creatinine ≤1.5 times the upper limit of normal; ast and alt ≤2.5 times the upper limit of normal (for patients with liver involvement ≤5 times the upper limit of normal); total bilirubin ≤1.5 times the upper limit of normal (for liver involvement patients ≤ 3 times the upper limit of normal); exclusion criteria: 1. the subject's previous history of anti-tumor therapy meets one of the following conditions: 1. those who have received mitoxantrone or mitoxantrone liposome in the past; 2. have received doxorubicin or other anthracycline therapy in the past, and the total cumulative dose of doxorubicin is more than 360 mg/m2 (1 mg doxorubicin equivalent to 2 mg epirubicin converted from other anthracyclines); 3. patients who have received autologous hematopoietic stem cell transplantation within 100 days of the first medication, or have received allogeneic hematopoietic stem cell transplantation; 4. received anti-tumor therapy (including chemotherapy, targeted therapy, hormone therapy, taking traditional chinese medicine with anti-tumor activity, etc.) or participated in other clinical trials and received clinical trial drugs within 4 weeks before the first use of the study drug; 2. hypersensitivity to any study drug or its components; 3. uncontrollable systemic diseases (such as advanced infection, uncontrollable hypertension, diabetes, etc.); 4. cardiac function and disease meet one of the following conditions: 1. long qtc syndrome or qtc interval \>480 ms; 2. complete left bundle branch block, second or third degree atrioventricular block; 3. severe, uncontrolled arrhythmia requiring medical treatment; 4. new york college of cardiology classification ≥ grade iii; 5. cardiac ejection fraction (lvef) less than 50%; 6. history of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia, or any other arrhythmia requiring treatment, clinically significant pericardial disease within 6 months prior to recruitment, or acute ischemic or active ecg evidence of conduction system abnormalities. 5. active infection of hepatitis b and c (hbv surface antigen positive and hepatitis b virus dna more than 1x103 copies/ml; hepatitis c virus rna more than 1x103 copies/ml); 6. human immunodeficiency virus (hiv) infection (hiv antibody positive); 7. past or present with other malignant tumors (except for effectively controlled non-melanoma skin basal cell carcinoma, breast/cervical carcinoma in situ, and other malignant tumors that have been effectively controlled without treatment within the past five years); 8. suffering from primary or secondary central nervous system (cns) lymphoma or a history of cns lymphoma at the time of recruitment; 9. there are obvious gastrointestinal diseases at the time of screening, which may affect the intake, transport or absorption of drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.); 10. pregnant, lactating women and patients of childbearing age who are unwilling to take contraceptive measures; 11. subjects with lymphoma and leukemia (proportion of malignant tumor cells in bone marrow examination\> 20%) circumstances judged by other investigators to be inappropriate to participate in this study. -

Keywords: relapsed and refractory peripheral t-cell lymphoma mitoxantrone liposomes